The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Resuscitation Timer, Model L770-cpr.
Device ID | K073171 |
510k Number | K073171 |
Device Name: | RESUSCITATION TIMER, MODEL L770-CPR |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
Contact | Wayne Karcher |
Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-09 |
Decision Date | 2008-01-31 |